Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2010-09-30

Brief Summary

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The purpose of the study is to assess whether spinal anesthesia is or not superior to the standard general anesthesia for fit patients undergoing laparoscopic cholecystectomy.

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Detailed Description

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Laparoscopic cholecystectomy under regional anesthesia alone has been reported only occasionally in the past; all these reports included patients unfit to receive general anesthesia, mainly patients with severe chronic obstructive airway disease. Regional anesthesia has been used for laparoscopy in fit patients almost exclusively in combination with general anesthesia, in order to extend the analgesic effect during the early postoperative period. Surprisingly, in the era of minimally invasive medicine, regional anesthesia has not gained popularity, and has not been routinely used as a sole method of anesthesia in laparoscopic procedures. It is generally accepted that all laparoscopic procedures are merely a change in access and still require general anesthetic; hence the difference from conventional surgery is likely to be small. This statement is predominantly based on the assumption that laparoscopy necessitates endotracheal intubation to prevent aspiration and respiratory embarrassment secondary to the induction of CO2 pneumoperitoneum which in turn is not well tolerated in a patient who is awake during the procedure. However, it is surprising that regional anesthesia has been successfully used for laparoscopic cholecystectomy in patients unfit to have the procedure under general anesthesia, but has not been tested in fit patients, in whom any presumed risk would be, theoretically, much lower. We have recently shown in a pilot study the feasibility to perform successfully and safely laparoscopic cholecystectomy with low pressure CO2 pneumoperitoneum under spinal anesthesia alone, in fit patients with symptomatic gallstone disease. We have also noticed that spinal anesthesia results in exceptionally minimal postoperative pain. After this pilot study, we designed a controlled randomized trial in order to compare spinal anesthesia with the standard general anesthesia for elective laparoscopic cholecystectomy in fit patients.

Conditions

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Spinal Anesthesia General Anesthesia Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Laparoscopic cholecystectomy under spinal anesthesia

Group Type ACTIVE_COMPARATOR

laparoscopic cholecystectomy

Intervention Type PROCEDURE

elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia

2

Laparoscopic cholecystectomy under general anesthesia

Group Type ACTIVE_COMPARATOR

laparoscopic cholecystectomy

Intervention Type PROCEDURE

elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia

Interventions

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laparoscopic cholecystectomy

elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* elective laparoscopic cholecystectomy
* ASA I, II
* BMI\< 30
* normal coagulation profile

Exclusion Criteria

* acute cholecystitis / cholangitis / pancreatitis
* previous open surgery in the upper abdomen
* contraindication for pneumoperitoneum
* contraindication for spinal anesthesia (ie spinal deformity)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes